Lemborexant (Dayvigo) is a new-type medication for treating insomnia. As an orexin receptor antagonist, it helps improve sleep by regulating the arousal system in the brain.

What are the Indications of Lemborexant (Dayvigo)?

Main Therapeutic Scope

Lemborexant is specifically indicated for adult patients with insomnia, targeting two typical symptoms: difficulty falling asleep and/or difficulty maintaining sleep.

Clinical studies have confirmed that this medication can effectively shorten sleep latency and improve sleep efficiency.

Characteristics of the Target Population

The insomnia symptoms targeted by this medication are specifically manifested as: a significant prolongation of time to fall asleep (sleep onset disorder), or frequent awakenings at night with difficulty maintaining continuous sleep (sleep maintenance disorder).

In two randomized controlled clinical trials, the age range of patients was 18 to 88 years old, among whom 28% were elderly patients aged 65 and above.

Dosage Forms, Specifications and Properties of Lemborexant (Dayvigo)

Dosage Forms and Specifications

5 mg tablets: Light yellow, round and biconvex, engraved with "5" on one side and "LЄM" on the other side.

10 mg tablets: Orange, also round and biconvex, engraved with "10" on one side and "LЄM" on the other side.

Composition

Active ingredient: Each tablet contains 5 mg or 10 mg of lemborexant.

Excipients: Hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. The film coating contains hypromellose 2910, polyethylene glycol 8000, talc, and titanium dioxide. Additionally, the 5 mg tablets contain yellow iron oxide, while the 10 mg tablets contain both yellow iron oxide and red iron oxide.

Storage and Preservation Requirements for Lemborexant (Dayvigo)

Standard Storage Conditions

Lemborexant must be stored at an ambient temperature of 20°C to 25°C (68°F to 77°F), with a permitted short-term fluctuation range of 15°C to 30°C (59°F to 86°F).

The room temperature requirements controlled by the USP (United States Pharmacopeia) must be strictly followed.

Key Points for Safe Storage

The medication is packaged in child-resistant packaging, available in two specifications: 30 tablets per package and 90 tablets per package.

To ensure medication safety, Lemborexant must be placed out of the reach of children to prevent accidental ingestion.

Special Precautions

Since Lemborexant is a controlled substance with risks of abuse and dependence, it must be properly stored to prevent illegal use or transfer of the medication.